2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction J O U R N A L.
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL 77, NO 6, 2021 ª 2021 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER EXPERT CONSENSUS DECISION PATHWAY 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction A Report of the American College of Cardiology Solution Set Oversight Committee Writing Thomas M Maddox, MD, MSC, FACC, Chair JoAnn Lindenfeld, MD, FACC Committee James L Januzzi, JR, MD, FACC, Vice Chair Frederick A Masoudi, MD, MSPH, FACC Shweta R Motiwala, MD, MPH Larry A Allen, MD, MHS, FACC Solution Set J Herbert Patterson, PHARMD Javed Butler, MD, MBA, MPH, FACC Mary Norine Walsh, MD, MACC Leslie L Davis, PHD, RN, ANP-BC, FACC Alan Wasserman, MD, FACC Gregg C Fonarow, MD, FACC Clyde W Yancy, MD, MSC, MACC Nasrien E Ibrahim, MD, FACC Quentin R Youmans, MD Ty J Gluckman, MD, FACC, Chair Chayakrit Krittanawong, MD Dharam J Kumbhani, MD, SM, FACC Oversight Committee Estefania Oliveros, MD, MSC Khadijah Breathett, MD, MS, FACC Niti R Aggarwal, MD, FACC Javier A Sala-Mercado, MD, PhD Nicole M Bhave, MD, FACC David E Winchester, MD, MS, FACC Gregory J Dehmer, MD, MACC Martha Gulati, MD, MS, FACC—Ex Officio Olivia N Gilbert, MD, MSc, FACC This document was approved by the American College of Cardiology Clinical Policy Approval Committee in November 2020 The American College of Cardiology requests that this document be cited as follows: Maddox TM, Januzzi JL Jr., Allen LA, Breathett K, Butler J, Davis LL, Fonarow GC, Ibrahim NE, Lindenfeld J, Masoudi FA, Motiwala SR, Oliveros E, Patterson JH, Walsh MN, Wasserman A, Yancy CW, Youmans QR 2021 update to the 2017 ACC expert consensus decision pathway for optimization of heart failure treatment: answers to 10 pivotal issues about heart failure with reduced ejection fraction: a report of the American College of Cardiology Solution Set Oversight Committee J Am Coll Cardiol 2021;77:772–810 Copies: This document is available on the website of the American College of Cardiology (http://www.acc.org) For copies of this document, please contact Elsevier Inc Reprint Department via fax (212 633-3820) or e-mail (reprints@elsevier.com) Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology Requests may be completed online via the Elsevier site (https://www.elsevier.com/about/policies/ copyright/permissions) ISSN 0735-1097/$36.00 https://doi.org/10.1016/j.jacc.2020.11.022 Maddox et al JACC VOL 77, NO 6, 2021 FEBRUARY 16, 2021:772–810 2021 Update to 2017 ECDP for Optimization of Heart Failure Treatment TABLE OF CONTENTS PREFACE 773 5.2.5 Biomarkers—When to Order Natriuretic Peptides 791 ABSTRACT 774 5.2.6 Filling Pressure Assessment—When and How to Measure Filling Pressures 792 INTRODUCTION 774 5.3 When to Refer to an HF Specialist 792 METHODS 775 5.4 How to Address Challenges of Care Coordination 792 ASSUMPTIONS AND DEFINITIONS 776 5.5 How to Improve Adherence 794 3.1 General Clinical Assumptions 776 5.5.1 Medication Nonadherence 794 3.2 Definitions 776 5.5.2 General Approaches to Improving Adherence 794 PATHWAY SUMMARY GRAPHIC 776 5.5.3 System and Policy to Promote Adherence 796 DESCRIPTION AND RATIONALE: ANSWERS TO 10 PIVOTAL ISSUES IN HF 777 5.1 How to Initiate, Add, or Switch to New Evidence-Based Guideline-Directed Therapy for HFrEF 777 5.1.1 Initiating GDMT 779 5.1.2 Angiotensin Receptor-Neprilysin Inhibitor 781 5.1.3 Initiation of an ARNI De Novo Without Prior Exposure to ACEI or ARB 784 5.1.4 Ivabradine 785 5.6 What Is Needed in Specific Patient Cohorts: African Americans, Older Adults, and the Frail 796 5.7 How to Manage Your Patients’ Cost and Access to HF Medications 797 5.8 How to Manage the Increasing Complexity of HF Management 798 5.9 How to Manage Common Comorbidities 800 5.10 How to Integrate Palliative Care and Transition to Hospice Care 800 DISCUSSIONS AND IMPLICATIONS OF 5.1.5 Sodium-Glucose Cotransporter-2 Inhibitors 786 PATHWAY 802 5.1.6 Consensus Pathway Algorithm for Initiation and Titration of HFrEF Therapies 787 ACC PRESIDENT AND STAFF 802 5.1.7 Severe Mitral Regurgitation and the Use of Transcatheter Mitral Valve Repair 787 Author Relationships With Industry and Other Entities (RELEVANT) 807 5.1.8 Patients in Whom New Therapies May Not Be Indicated 787 5.2 How to Achieve Optimal Therapy Given Multiple Drugs for HF Including Augmented Clinical Assessment That May Trigger Additional Changes in GDMT (e.g., Imaging Data, Biomarkers, and Filling Pressures) 787 5.2.1 Target Doses 787 APPENDIX APPENDIX Peer Reviewer Information 809 APPENDIX Abbreviations 810 PREFACE 5.2.2 Barriers to Medication Titration 788 5.2.3 Clinical Assessment 789 The American College of Cardiology (ACC) has a long 5.2.4 Imaging—When to Order an Echocardiogram 789 history of developing documents (e.g., decision pathways, health policy statements, appropriate use criteria) 773 774 Maddox et al JACC VOL 77, NO 6, 2021 FEBRUARY 16, 2021:772–810 2021 Update to 2017 ECDP for Optimization of Heart Failure Treatment to provide members with guidance on both clinical and ABSTRACT nonclinical topics relevant to cardiovascular (CV) care In most circumstances, these documents have been created The 2017 ACC Expert Consensus Decision Pathway for to complement clinical practice guidelines and to inform Optimization of Heart Failure Treatment was created to clinicians about areas where evidence may be new and provide a practical, streamlined resource for clinicians evolving or where sufficient data may be more limited managing patients with heart failure with reduced ejec- Despite this, numerous care gaps continue to exist, tion fraction (HFrEF) (2) The 2017 ECDP was based on the highlighting the need for more streamlined and efficient 2013 ACCF/American Heart Association (AHA) Guideline processes to implement best practices in service to for the Management of Heart Failure and the 2017 ACC/ improved patient care AHA/Heart Failure Society of America (HFSA) Focused Central to the ACC’s strategic plan is the generation of Update of the 2013 Guideline (3,4) The 2017 ECDP pro- “actionable knowledge”—a concept that places emphasis vided guidance on introducing the numerous evidence- on making clinical information easier to consume, share, based integrate, and update To this end, the ACC has evolved treatment barriers, acknowledging contraindications and from developing isolated documents to developing inte- situations for which little data exist, affording expensive grated “solution sets.” Solution sets are groups of closely therapies, treating special cohorts, and making the tran- related activities, policy, mobile applications, decision sition to palliative care Rather than focusing on extensive support, and other tools necessary to transform care and/ text, the document provided practical tips, tables, and or improve heart health Solution sets address key ques- figures to make clear the steps, tools, and provisos needed tions facing care teams and attempt to provide practical to successfully and expeditiously treat the patient with guidance to be applied at the point of care They use both HFrEF Many of the pivotal issues addressed in the ECDP established and emerging methods to disseminate infor- were not the substance of clinical trials; rather, they mation for CV conditions and their related management represent the challenge of clinical practice therapies, improving adherence, overcoming The success of the solution sets rests firmly on their Since the 2017 ECDP, new therapies for HFrEF have ability to have a measurable impact on the delivery of emerged that expand the armamentarium for the treat- care Because solution sets reflect current evidence and ment of patients with HFrEF In particular, the emergence ongoing gaps in care, the associated content will be of angiotensin receptor-neprilysin inhibitors (ARNIs), refined over time to best match changing evidence and sodium-glucose cotransporter-2 (SGLT2) inhibitors, and member needs percutaneous therapy for mitral regurgitation (MR) Expert consensus decision pathways (ECDPs) represent represent significant advances in the treatment of HFrEF a key component of solution sets The methodology for As such, a focused update to the 2017 ECDP that in- ECDPs is grounded in assembling a group of clinical ex- corporates these advances into the recommendations is perts to develop content that addresses key questions warranted This update can serve as interim guidance to facing our members across a range of high-value clinical clinicians while we await the comprehensive and defini- topics (1) This content is used to inform the development tive heart failure (HF) guideline update under develop- of various tools that accelerate real-time use of clinical ment by the ACC The treatment of HFrEF can feel policy at the point of care They are not intended to pro- overwhelming, and many opportunities to improve pa- vide a single correct answer; rather, they encourage cli- tient outcomes are being missed; hopefully, this ECDP nicians to ask questions and consider important factors as will streamline care to realize the best possible patient they define treatment plans for their patients Whenever outcomes in HF appropriate, ECDPs seek to provide unified articulation of clinical practice guidelines, appropriate use criteria, and INTRODUCTION other related ACC clinical policy In some cases, covered topics will be addressed in subsequent clinical practice The prevalence of HF is escalating rapidly (5) Com- guidelines as the evidence base evolves In other cases, pounding this, HF is an illness that consumes substantial these will serve as stand-alone policy healthcare resources, inflicts considerable morbidity and Ty J Gluckman, MD, FACC mortality, and greatly affects quality of life Important Chair, ACC Solution Set Oversight Committee breakthroughs have redefined opportunities to change Maddox et al JACC VOL 77, NO 6, 2021 FEBRUARY 16, 2021:772–810 2021 Update to 2017 ECDP for Optimization of Heart Failure Treatment the natural history of the disease with a broad range of the ACC Heart House Participants attending the HF medical therapies, devices, and care strategies roundtable included cardiologists, internists, emergency The purpose of this focused ECDP update is to sup- physicians, hospitalists, nurses, representatives from pa- plement the 2017 ECDP with data from emerging studies tient advocacy groups, pharmacists, fellows-in-training, and to continue to provide succinct, practical guidance for quality managing patients with HFrEF The format of the 10 biostatisticians improvement experts, epidemiologists, and Pivotal Issues in the 2017 ECDP was preserved, and their Since the publication of the 2017 ECDP, numerous associated treatment algorithms and tables have been clinical trials have been reported, providing updated updated to accommodate this new, evolving evidence knowledge to inform the clinical management of patients with HFrEF In addition, more knowledge is now available Ten Pivotal Issues in HFrEF regarding biomarkers and imaging, management of How to initiate, add, or switch therapies to new evidence-based guideline-directed treatments for HFrEF How to achieve optimal therapy given multiple drugs comorbidities, and the mitigation of difficulties encountered in care coordination Lastly, the considerable impact of the coronavirus disease 2019 (COVID-19) pandemic on outpatient management of chronic disease for HF including augmented clinical assessment (e.g., states such as HFrEF justifies its consideration in this imaging data, biomarkers, and filling pressures) that document may trigger additional changes in guideline-directed therapy To address these newer data and how they relate to prior logic for clinical management of HFrEF, the ACC When to refer to an HF specialist convened structured discussions to address new thera- How to address challenges of care coordination pies, unanswered questions, adherence, and imple- How to improve medication adherence mentation What is needed in specific patient cohorts: African multidisciplinary panel discussions, which have been Americans, older adults, and the frail How to manage your patients’ costs and access to HF medications strategies The College also convened archived for online distribution (https://www.acc.org/ tools-and-practice-support/quality-programs/succeed-inmanaging-heart-failure-initiative/emerging-strategies-for- How to manage the increasing complexity of HF heart-failure-roundtable) Based on those discussions, a How to manage common comorbidities writing committee was formed to provide practical guid- 10 How to integrate palliative care and the transition into hospice care ance to address gaps in care related to optimal management of HF treatment For this 2021 update, the writing committee convened in mid-2020 on confidential con- METHODS ference calls attended only by writing committee members and ACC staff When consensus within the writing The original 2017 ACC ECDP was drafted using a struc- committee was deemed necessary by the Chair and Vice tured format that was created subsequent to the release of Chair, either a roll call vote or an email-generated ballot the 2016 and 2017 ACC/AHA/HFSA focused updates of the was implemented A simple majority prevailed; in the 2013 ACCF/AHA HF guideline (2,4,6) The evolution of presence of a tie, the Chair’s prerogative reconciled the that ECDP involved developing questions to identify ev- final decision idence gaps and convening a multidisciplinary panel of The formal peer-review process was completed stakeholders who carried out a literature review to consistent with ACC policy and included a public aggregate relevant evidence addressing contemporary HF comment period to obtain further feedback Following care At that time, the references were separately reconciliation of all comments, this document was reviewed by the Chair and Vice Chair of the ECDP, and an approved for publication by the Clinical Policy Approval agreed-upon compendium was developed Print copies of Committee the references were provided to each member of the panel The ACC and the Solution Set Oversight Committee before a live roundtable meeting held on July 19, 2016, at (SSOC) recognize the importance of avoiding real or 775 776 Maddox et al JACC VOL 77, NO 6, 2021 FEBRUARY 16, 2021:772–810 2021 Update to 2017 ECDP for Optimization of Heart Failure Treatment perceived relationships with industry (RWI) or other en- specialist, and/or a disease management program, and/ tities that may affect clinical policy The ACC maintains a or other relevant medical specialists (e.g., endocrinol- database that tracks all relevant relationships for ACC ogists or nephrologists) to guide clinical management members and persons who participate in ACC activities, In all cases, patient preferences and values, in part- including those involved in the development of ECDPs nership with evidence-based clinical judgment, should ECDPs follow ACC RWI Policy in determining what constitutes a relevant relationship, with additional vetting by guide clinical decision-making At any point in time, these suggestions and algorithms the SSOC may be superseded by new data ECDP writing groups must be chaired or co-chaired by an individual with no relevant RWI Although vice chairs and writing group members may have relevant RWI, they must constitute